Drug product
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
D-0516-2019
Product summary
- Event
- Event 82158
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 2,413 bottles b) 3,355 bottles
- Official record key
drug-enforcement:D-0516-2019
Official wording
Reason: Failed dissolution specifications
Code information: Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
Distribution pattern: Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications